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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038528
Receipt No. R000043719
Scientific Title Examination of educational effects and influencing factors of complex exercise programs for elderly people participating in community-based attendance.cluster randomized controlled trial
Date of disclosure of the study information 2019/11/09
Last modified on 2019/11/09

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Basic information
Public title Examination of educational effects and influencing factors of complex exercise programs for elderly people participating in community-based attendance.cluster randomized controlled trial
Acronym Examination of educational effects and influencing factors of complex exercise programs for elderly people participating in community-based attendance.cluster randomized controlled trial
Scientific Title Examination of educational effects and influencing factors of complex exercise programs for elderly people participating in community-based attendance.cluster randomized controlled trial
Scientific Title:Acronym Examination of educational effects and influencing factors of complex exercise programs for elderly people participating in community-based attendance.cluster randomized controlled trial
Region
Japan

Condition
Condition Elderly people
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the educational effects of exercise programs and brain activation programs for elderly people participating in community-based places of attendance.
Basic objectives2 Others
Basic objectives -Others Consider factors that affect effectiveness.
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cognitive function
Key secondary outcomes 1)Motor function.
Grip strength, long-bend bend, 30 second chair standing up test, standing on one leg.
2)Comprehensive activity
Life-Space Assessment, Falls Efficacy Scale, Bathing action, Continuous walking distance, Lubben Social Network Scale(LSNS-6)
3)Social capital indicators.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 One video gymnastics instruction for stretching and strength training.
Video exercise for stretching and strength training 30 minutes,24 weeks of activity frequency at the place of attendance.
Interventions/Control_2 One instruction for video exercises for stretching and strength training, and two instructions for brain activation program.
Video exercise for stretching and strength training 30 minutes + brain activation program 10 minutes through the activity frequency of the place for 24 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria cluster
1)It is a communal place that municipalities judge to do gymnastics and hobbies, and to help prevent nursing care
2)Residents are responsible for managing the attendance
3)The management of commuting places is not limited to those where municipalities provide financial support
4)Have an activity record of at least once a month
Individual unit
1)Those who are at risk or who are concerned about their health condition have obtained a doctor's consent form
Key exclusion criteria cluster
1)A place for attendance of up to 7 participants
Individual unit
1)Doctors determined that study participation is inappropriate
2)Those with cardiovascular, respiratory, neurological or orthopedic disorders that limit the performance of exercise and assessment
3)Persons with dysarthria or aphasia who cannot communicate
4)Those under 65 years old
Target sample size 58

Research contact person
Name of lead principal investigator
1st name Yusuke
Middle name
Last name Sakata
Organization Chizu hospital
Division name Department of rehabilitation
Zip code 6891402
Address 1875 Chizu town,Tottori,Japan
TEL 0858-75-3211
Email chizu-riha-pt@town.chizu.tottori.jp

Public contact
Name of contact person
1st name Yusuke
Middle name
Last name Sakata
Organization Chizu hospital
Division name Department of rehabilitation
Zip code 6891402
Address 1875 Chizu town,Tottori,Japan
TEL 0858-75-3211
Homepage URL
Email chizu-riha-pt@town.chizu.tottori.jp

Sponsor
Institute Chizu hospital
Department of rehabilitation
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research ethics committee of Japan Physical Therapy Association
Address 3-8-5 Sendagaya,Sibuya,Tokyo,Japan
Tel 03-6804-1626
Email ethics@japanpt.or.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 09 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 08 Month 19 Day
Date of IRB
Anticipated trial start date
2019 Year 11 Month 15 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 09 Day
Last modified on
2019 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043719

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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